The invention relates generally to methods and devices for filtering pharmaceutical products.
During a pharmaceutical compounding process one or more chemical components are required to be removed from the end product for safety or efficacy purposes. As used herein, the term “chemical components” refers to one or more chemicals present in the initial mixture used to prepare the pharmaceutical product. The chemical components may include any form of compounds intentionally added to, or present from material impurities, or present from contamination of an unrefined pharmaceutical product that are not desired in the end pharmaceutical product. Various methods of filtration and separation are known in the art for removing—chemical components from a mixture to obtain a pharmaceutical product that is suitable to be administered to a subject. The conventional removal methods typically require use of solvents or materials that unintentionally add further matter to the mixture that is not desired in the final pharmaceutical product. The undesired matter needs to be removed from the device before conducting the filtration process. This undesired matter may include solvents that are used to prepare the device to perform the filtration or separation or solvents or materials added to the mixture. Alternatively, this undesired matter may also include biologically relevant materials such as endotoxins, proteins, nucleic acids, bacteria or viruses that are contained within the conditioning system or solvents and are subsequently introduced to the filtration device. The additional steps involving addition and subsequent removal of solvents and other materials from the device or the mixture adds to the complexity of the filtration process and to the complexity of the process equipment. Further, these additional steps result in longer time duration for the overall filtration process. Furthermore, quality control mechanisms are required to ensure that the undesired matter is not carried in to the pharmaceutical product. In addition, there is a chance of contamination of the mixture due to extraneous material entering the filtering device while carrying out the steps of administering and removing the undesired matter from the device.
Therefore, there is a need to explore new methods and devices for filtration of pharmaceutical products that do not require addition of solvents or other materials to the filtration device or to the pharmaceutical mixture and that are relatively easier to perform. Further, there is a need for new methods and devices that can be pre-conditioned and stored, such that these devices are ready to use for filtration without conducting any further steps for conditioning the device immediately prior to filtration. Furthermore, there is a need for a device that is sealed to prevent any extraneous material from entering the device either before or during filtration, or once the device is prepared and stored for filtration.